Iwańczak Barbara M, Ryżko Józef, Jankowski Piotr, Sładek Małgorzata, Wasilewska Agata, Szczepanik Mariusz, Sienkiewicz Edyta, Szaflarska-Popławska Anna, Więcek Sabina, Czaja-Bulsa Grażyna, Korczowski Bartosz, Maślana Jolanta, Iwańczak Franciszek, Kacperska Magdalena
Department and Clinic of Paediatrics, Gastroenterology and Nutrition, Wroclaw Medical University, Poland.
Children's Memorial Health Institute, Warsaw, Poland.
Adv Clin Exp Med. 2017 Jan-Feb;26(1):51-56. doi: 10.17219/acem/35802.
Registration of infliximab in Poland has increased chances to induce clinical remission and mucosal healing in the severe form of pediatric Crohn's disease.
The aim of this retrospective study was to assess the results and safety of infliximab therapy in the severe form of pediatric Crohn's disease.
The study included 153 children with severe form of non-fistulizing Crohn's disease treated with infliximab. The clinical activity of Crohn's disease was assessed according to PCDAI scale, endoscopic scoring was graded according to SES-CD, body mass was measured with body mass index (BMI). Infliximab was administered at the dose 5 mg/kg body mass in the 0.2 and 6th week, and then, after clinical response, every 8 for the period of 12 months.
One hundred thirty-six children (88.89%) achieved clinical response after induction therapy and 75.21% of children after the maintenance therapy. 39.68% of children achieved remission as graded with endoscopic scoring SES-CD. There was a statistically significant increase in body weight following the treatment. Side effects such as anaphylaxis, rash, and the activation of EBV infection appeared in 9 children at the time of infliximab injection. In other children the drug was well tolerated.
Induction and maintenance therapy with infliximab resulted in clinical remission of Crohn's disease in 75.21% of children, and in the intestinal mucosa healing in 39.68% of children.
英夫利昔单抗在波兰获批注册，增加了重度小儿克罗恩病实现临床缓解和黏膜愈合的机会。
本回顾性研究旨在评估英夫利昔单抗治疗重度小儿克罗恩病的疗效和安全性。
本研究纳入了153例接受英夫利昔单抗治疗的重度非瘘管型克罗恩病患儿。根据PCDAI量表评估克罗恩病的临床活动度，根据SES-CD进行内镜评分，通过体重指数（BMI）测量体重。英夫利昔单抗以5mg/kg体重的剂量在第0、2和6周给药，然后在临床缓解后，每8周给药一次，持续12个月。
136例患儿（88.89%）在诱导治疗后实现临床缓解，75.21%的患儿在维持治疗后实现临床缓解。39.68%的患儿在内镜评分SES-CD中达到缓解。治疗后体重有统计学意义的增加。9例患儿在注射英夫利昔单抗时出现过敏反应、皮疹和EBV感染激活等副作用。其他患儿对该药物耐受性良好。
英夫利昔单抗的诱导和维持治疗使75.21%的患儿实现克罗恩病临床缓解，39.68%的患儿实现肠黏膜愈合。
